Articles

TGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.

The TGA is aware of several incorrect recent media reports asserting that some COVID-19 rapid antigen tests have been removed from the market by the TGA for failing to detect the Omicron COVID-19 variant.

TGA has released over 95 batches of influenza vaccine, consisting of over 16.8 million doses, for supply in Australia for the 2022 influenza season.

The TGA has commenced Federal Court proceedings against Vapor Kings Pty Ltd and its sole director for alleged unlawful advertising of nicotine vaping products.

The TGA has provisionally approved the Biocelect Pty Ltd (on behalf of Novavax Inc.) COVID-19 vaccine, NUVAXOVID, for use in individuals aged 12 years and older.

The TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.

This labelling exemption is granted under section 1.1(3) of Part 2 of the current Poisons Standard.

The TGA has issued 12 infringement notices totalling $31,698 to a NSW based individual for alleged unlawful advertising of disposable nicotine vaping products on several websites.

The TGA has issued a direction notice to Phenix Health Pty Ltd to cease alleged unlawful advertising of nicotine vaping products.

The TGA has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years (6 months to 5 years).

On 5 July 2022 the TGA granted two provisional determinations to Pfizer Australia Pty Ltd.

Precision Pharmaceuticals Pty Ltd fined and directed to cease alleged unlawful advertising of nicotine vaping products

Direction Notice issued to cease advertisement of prescription and illegal products

On 28 June 2022 the TGA granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, COMIRNATY.

The TGA has issued eight (8) infringement notices totalling $106,560 to Hough Pharma Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 RATs.

This Order revokes Therapeutic Goods (Groups) Order No. 1 of 1992.

This Order may be cited as Therapeutic Goods (Groups) Order No. 1 of 1992.

This Order revokes Therapeutic Goods (Groups) Order No. 1 of 1991.

The TGA has commenced court proceedings in the Federal Court of Australia against Prefixx Pty Ltd and its sole director for alleged unlawful advertising of nicotine vaping products.

The transition period from the 2018 to the 2021 Advertising Code ends 30 June 2022.

The TGA has issued one infringement notice totalling $2,664 to a Queensland based individual for alleged unlawful advertising of therapeutic goods in relation to COVID-19.

The TGA has issued four infringement notices totalling $10,664 to an individual for alleged unlawful importation of COVID-19 rapid antigen tests (RATs).

The TGA has issued one infringement notice of $2,664 to a NSW based individual for the alleged unlawful advertising of a medicine that was not included in the Australian Register of Therapeutic Goods.

The TGA has issued ten infringement notices totalling $133,200 to Philips Electronics Australia Ltd.

The TGA has issued 15 infringement notices totalling $39,960 to a New South Wales based individual for alleged unlawful importation of the prescription-only medicines ivermectin and doxycycline.